BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 2780031 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12958
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 7, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ICD REMAINS IN SERVICE. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, SHORTLY AFTER IMPLANT, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED HIGH OUT OF RANGE (OOR) SHOCK IMPEDANCE MEASUREMENTS IN ALL THREE VECTORS. TECHNICAL SERVICES (TS) SUGGESTED PERFORMING AN X-RAY, AND A LOW SHOCK TEST TO ASSESS WHETHER THIS IS A CONNECTION ISSUE OR LEAD ISSUE. THIS PATIENT WILL BE FOLLOWED-UP WITHIN THE NEAR FUTURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. SUBSEQUENTLY, THE PHYSICIAN DELIVERED A 1.1 JOULE SHOCK, AND IMPEDANCE MEASUREMENT WAS 46 OHMS. SHORTLY AFTER THE DELIVERED SHOCK, THE IMPEDANCE AGAIN INCREASED TO GREATER THAN 125 OHMS. TS REVIEWED AN X-RAY AND DISCUSSED THERE COULD POTENTIALLY BE UNDERINSERTION. TS REQUESTED A SAVE ALL TO DISK, A MEMORY DOWNLOAD, AND A BETTER X-RAY OR FLUOROSCOPY BE PERFORMED TO BETTER EVALUATE LEAD INSERTION INTO THE HEADER. AT THIS TIME, HOWEVER, NO FURTHER INTERVENTION IS PLANNED. THE PHYSICIAN ELECTED TO DISCHARGE THE PATIENT DUE TO NORMAL IMPEDANCE MEASUREMENTS AFTER THE LOW ENERGY 1.1 JOULE SHOCK. THE PATIENT DID NOT RECEIVE ANY THERAPY WITH HIS PREVIOUS DEVICE, SO THE PHYSICIAN DID NOT FEEL THIS WAS AN URGENT MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F141

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening